UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063456 |
|---|---|
| Receipt number | R000072489 |
| Scientific Title | Prospective Observational Study on the Association Between Venous Congestion and Anastomotic Leakage During Colorectal Cancer Surgery Using Intraoperative Ultrasound and Oxygen Saturation Endoscopic Imaging |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/10/29 12:40:35 |
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Basic information
Public title
Evaluation of Venous Congestion and Anastomotic Leakage in Colorectal Cancer Surgery Using Intraoperative Ultrasound and Oxygen Saturation Imaging
Acronym
COLO-VEIN Study
(COLOrectal Venous Evaluation & Imaging for New Insights)
Scientific Title
Prospective Observational Study on the Association Between Venous Congestion and Anastomotic Leakage During Colorectal Cancer Surgery Using Intraoperative Ultrasound and Oxygen Saturation Endoscopic Imaging
Scientific Title:Acronym
OXEI-US-AL Study
Region
| Japan |
Condition
Condition
Colorectal Cancer (Sigmoid Colon Cancer, Rectal Cancer)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and quantify intraoperative venous congestion caused by inferior mesenteric vein (IMV) ligation during left-sided colorectal cancer surgery by integrating morphological assessment via intraoperative ultrasound (US) and functional assessment via oxygen saturation endoscopic imaging (OXEI), thereby investigating clinical cutoff values for predicting anastomotic leakage (AL).
Basic objectives2
Others
Basic objectives -Others
Intraoperative prediction of anastomotic leakage and quantitative evaluation of local venous hemodynamics and microcirculation after inferior mesenteric vein ligation in colorectal cancer surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictive performance for anastomotic leakage (AL) evaluated by ROC-AUC, optimal cutoff values, sensitivity, specificity, and negative predictive value (NPV), using the venous expansion ratio (%) measured by intraoperative ultrasound (US) and tissue oxygen saturation (StO2) decline rate (%) measured by oxygen saturation endoscopic imaging (OXEI).
Assessment timing: Intraoperatively and within 30 days postoperatively
Key secondary outcomes
1. Correlation between the US-measured venous expansion ratio (%) and OXEI-measured StO2 decline rate (%) before and after IMV ligation.
2. Incidence of postoperative anastomotic leakage (minor and major AL).
3. Incidence of overall postoperative complications classified by Clavien-Dindo grade.
4. Postoperative length of hospital stay (days).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal adenocarcinoma
2. Undergoing left-sided colectomy, sigmoidectomy, anterior resection, or low anterior resection with planned primary anastomosis
3. Primary anastomosis located within 15 cm from the anal verge
4. Informed consent obtained via IRB-approved method
Key exclusion criteria
1. Procedures without primary anastomosis, e.g., Hartmann's procedure
2. Emergency surgical operations
3. Severe systemic vascular diseases affecting bowel perfusion
4. Patients judged inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hotta |
Organization
Nippon Medical School Tamanagayama Hospital
Division name
Department of GI and HPB Surgery
Zip code
206-8512
Address
1-7-1, Nagayama, Tama City,Tokyo, Japan
TEL
0423712111
s9083@nms.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hotta |
Organization
Nippon Medical School Tamanagayama Hospital
Division name
Department of GI and HPB Surgery
Zip code
206-8512
Address
1-7-1, Nagayama, Tama City,Tokyo, Japan
TEL
0423712111
Homepage URL
s9083@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Masahiro Hotta
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Tamanagayama Hospital
Address
1-7-1, Nagayama, Tama City,Tokyo, Japan
Tel
0423712111
s9083@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学多摩永山病院 消化器外科/Department of GI and HPB Surgery, Nippon Medical School Tamanagayama Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.This is a prospective observational study conducted under Institutional Review Board approval (Nippon Medical School IRB Approval No. F-2024-142). Registration in this registry was completed prior to the initiation of statistical data analysis.
2.The oxygen saturation endoscopic imaging (OXEI) platform used in this study is a commercially available medical device cleared by the US FDA 510(k) and approved by the PMDA in Japan (Fujifilm Corp., Tokyo, Japan).
3.Image analysis of intraoperative ultrasound (US) measurements is performed using ImageJ software by independent assessors who are blinded to patient clinical outcomes, including anastomotic leakage.
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072489
